NCT02886910

Chorioamnionitis: Observation of at Risk Infants vs Standard Care

Chorioamnionitis: Observation of at Risk Infants vs Standard Care. Randomized Controlled Trial.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 10 Minutes – 6 Hours
• Healthy volunteers: Not accepted

Summary

This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood count, blood culture) and clinical observation by standardized physical examination versus the algorithm suggested in the CDC's 2010 guidelines (limited evaluation, clinical observation and antibiotic therapy) in the management of asymptomatic infants born at term to mothers with suspected chorioamnionitis. The primary outcome of the study is the difference in the prevalence of sepsis-related symptoms between the two groups.

Detailed description

Chorioamnionitis complicates 1-3% of pregnancies at term. The current international guidelines of the Center for Disease Control (CDC 2010) recommend that all asymptomatic newborns born to mothers with suspected chorioamnionitis undergo limited evaluation (i.e. blood culture at birth and complete blood count) and antibiotic therapy until the blood culture result is available. However, the prevalence of positive blood cultures in infants born to mothers with suspected chorioamnionitis is low, approximately 1%, including also infants requiring intensive care. This prevalence is even lower in asymptomatic infants. Moreover, the efficacy of antibiotic prophylaxis in preventing early sepsis, death or long-term sequelae in asymptomatic infants born to mothers with suspected chorioamnionitis has not been demonstrated. Early antibiotic use has been related to obesity and to the modification of microbiota. Limiting antibiotic use may prevent the emergence of antibiotic-resistant bacteria. Clinical observation is a reliable method to recognize infants with sepsis.

Conditions

• Chorioamnionitis
• Early Onset Neonatal Sepsis
• Sepsis of the Newborn

Interventions

Type	Name	Description
OTHER	Clinical observation	Antibiotics will be started only if sepsis-related signs or symptoms are present.Clinical observation consists in a standardized physical examination protocol according to which newborns are observed by the nurses at 1, 2, 4, 8, 12, 16, 20, 24 hours of life and then every 6 hours up to 48 hours of life. The following signs and symptoms are checked: skin colour (pink/pale/cyanotic/mottled), respiratory rate (lower or higher than 60 breaths/minute) and presence or absence of respiratory distress.
OTHER	Standard management	Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2019-11-01
• First posted: 2016-09-01
• Last updated: 2019-07-12

Locations

1 site across 1 country: Italy